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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00249457
Other study ID # NIDA-13107-2
Secondary ID
Status Completed
Phase N/A
First received November 3, 2005
Last updated October 26, 2017
Start date October 1996
Est. completion date January 2006

Study information

Verified date October 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.


Description:

The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.

Exclusion Criteria:

- Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).

Study Design


Intervention

Behavioral:
Contingency management
Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.

Locations

Country Name City State
United States The Center for Learning and Health Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aklin WM, Wong CJ, Hampton J, Svikis DS, Stitzer ML, Bigelow GE, Silverman K. A therapeutic workplace for the long-term treatment of drug addiction and unemployment: eight-year outcomes of a social business intervention. J Subst Abuse Treat. 2014 Nov-Dec; — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of urine samples at the assessments that were negative for cocaine (total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100 every 30 days throughout fourth year
Primary Percentage of urine samples at the assessments that were negative for opiates (total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100 every 30 days throughout fourth year
Primary Percentage of urine samples at the assessments that were negative for cocaine and opiates (total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100 every 30 days throughout fourth year
Secondary HIV risk behaviors every 30 days throughout fourth year
Secondary Percentage of participants employed each month every 30 days throughout fourth year
Secondary Number of days employed each month every 30 days throughout fourth year
Secondary Percentage of participants to self-report abstinence at all time points every 30 days throughout fourth year
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